Auditor / Inspection Manager (m/w/d).

Job ID: 11458

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Type of employment
Project Consulting
Company
Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.
Responsibilities
  • Support the preparation for authorities and customer inspections
  • Support internal/external development projects within Chemical and Analytical Development
  • Approve specifications and test procedures for raw materials, intermediates, packaging materials and APIs
  • Define and implement quality standards for GMP-processes within Chemical and Analytical Development
  • Evaluate and approve changes, deviations, validations and qualification documents
  • Review of Master Batch records and executed Batch records
  • Prepare and monitor supplier qualifications of raw materials, intermediates and APIs for external projects
Requirements
  • University degree (PhD) in Chemistry, Pharmacy or Biochemistry
  • Several years of working experience in development functions or product supply 
  • Knowledge of chemical production, quality control, quality assurance and international drug laws
  • Strong GMP understanding in the area of chemical and analytical development and production
  • Expertise in the development of peptides and oligonucleotides projects (Nice to have)
  • Fluency in German and English, both written and spoken
Region
West